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Completed

NCT Number: NCT02388282

A New Method for Estimating Dynamic Intrinsic PEEP

Dinamic intrinsic PEEP is

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sant'Orsola Malpighi

Bologna, 40185, Italy

About this study

Dynamic intrinsic positive end-expiratory pressure (PEEPi dyn) play an important pathophysiology role in many acute respiratory pathologies.

The most accurate method to quantify PEEPi dyn is to measure the rise in transdiaphragmatic pressure (Pdi) at end expiration at the point of the contraction of the inspiratory muscles until inspiratory flow starts.

Such method, however, is invasive, poor comfortable and require patient active collaboration.

The purpose of this study is describe a new non-invasive method for estimate PEEPi dyn and validate this method with gold-standard-one.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Acute or chronic respiratory failure
  • Age >=18 y

Exclusion criteria

  • Lack of informed consent
  • Controindication to the placement of oesophageal and gastric catheter:

esophageal varices, gastric or oesophageal bleeding in the previous 30 days, gastric or oesophageal surgery in the preceding year.

  • Cardiac arrest
  • Severe emodinamic instability (> 1 vasoacttive drug)
  • Acute coronary syndrome (AMI/UA)
  • Inability to protect airway
  • Respiratory arrest
  • Pregnancy suspected or confirmed
  • Diaphragm palsy
  • Curarization in the preceding five hours
  • Mechanical ventilation in controlled mode.

Treatment and study plan

diaphragm ecography

Device

recording of diaphragm ecography

Primary outcomes

  1. Correlation and agreement between AutoPEEP recorded with the transdiaphragmatic pressure (Pdi) vs ecography measurements.

    Time frame: 20 minutes

Secondary outcomes

  1. Correlation and agreement between neural inspiratory time and ecographic inspiratory time

    Time frame: 10 minutes

  2. Inter-rater agreement to assest method reliability

    Time frame: 10 minutes

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Official study title

A New Method for Estimating Dynamic Positive End-expiratory Pressure. Description and Validation With PEEPi Dyn Measured With Transdiaphragmatic Pressure

Acronym: echoPEEPi

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Mar 17, 2015
Registry last updated
Dec 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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